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Canadian patent ruling on Viagra a potential cure for drug industry

By not revealing the effective ingredient in Viagra, Pfizer lost its patent protection in Canada. (Dreamstime)

By John Greiss

Sun., Dec. 2, 2012

It’s a rare thing for the media to report on intellectual property law, and rarer still for the world to take notice of Canada’s patent decisions. But when the Supreme Court of Canada struck down the patent for Viagra last month, a lot of people stood up. The decision could pave the way for Canada to lead the world in improving the state of pharmaceutical regulation.

You see, the patent for Pfizer’s Viagra was one that we would expect as a society to be upheld. Scientists had discovered the effect of a certain molecule while studying its use in a totally unrelated disease, and then pivoted their focus to help in what previously had been treatable only by direct injections to the affected area. Surely this was a breakthrough discovery, and its blockbuster status reflects in part just how important an advance it was. If patents are expected to reward anything, it’s these types of novel discoveries that can help millions of people.

But Pfizer’s legal team covered it up. They buried their discovery among a quintillion — yes, quintillion — other molecules listed on the patent so that scientists could not easily discern which was the active molecule. The Supreme Court wasn’t happy, and in its decision described Canada’s patent law as a bargain: you tell us what you invented, and we’ll stop people from copying it. Pfizer failed to reveal its discovery and so lost its monopoly. Disclosure, in other words, was the key to patent protection.

Disclosure is an extremely important topic in today’s world of medicine. Recently, British physician Dr. Ben Goldacre released a book outlining just how badly the pharmaceutical industry fails to disclose important information. He focuses on how the companies have failed to provide full disclosure of the evidence for the medications that sell.

That information, he argues, is important for doctors and health-care practitioners to make critical health decisions. For example, the scare of a flu epidemic has caused governments around the world to stockpile millions of doses of Tamiflu, made by Roche. However, researchers now suspect that Tamiflu may be no better than a placebo, and the widely respected British Medical Journal has called for a boycott of all of Roche’s products until it releases all the evidence about the drug.

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The situation is so bad that in some cases, the failure to disclose information has led to patient deaths, as we saw with Vioxx and Avandia only recently. Meanwhile, the pharmaceutical companies have enjoyed record-breaking profits year over year based on the monopoly that we, as a society, give them for those very same products through patent protection.

Moreover, reports show that the companies are not putting that money back into research and development. Instead, they are lobbying government to extend their patent protection through various trade deals with Europe and the Pacific Rim. Anyone can see — this isn’t right.

A Senate committee recently released a report about improving the quality of clinical trial evidence in Canada. Health Minister Leona Aglukkaq also recently announced a system that would have companies register their clinical trials in a public registry, but the effort is — if you’ll excuse the expression — quite flaccid. What we need is a system that encourages companies to bring to market new discoveries like Viagra, but penalizes them when they don’t share the information.

And that’s where the Supreme Court of Canada may have pointed the way.

Let’s tie pharmaceutical patent protection to data disclosure. Let’s put the pharmaceutical companies on notice that if we discover they have withheld critical information about the products they bring to market, they’ll risk losing their patent protection.

It’s not a perfect fix, but it’s the first step toward filtering out useless products like Tamiflu, while improving access to data that clinicians and scientists need to make important decisions about our health and well-being. And the money we save can be put toward medical interventions that actually work.

As we look toward 2013, we still don’t have a good medication to help reduce the risk of complications associated with influenza. But if the federal government can take a cue from the country’s highest court, it may just be that Viagra will turn out to be the cure for the flu.

John Greiss is a pharmacist and the author of 7drams.ca where he writes about pharmaceutical and health policy in Canada.

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